Two phase III studies show efficacy and safety of Exparel (bupivacaine liposome injectable suspension) in surgical procedures- Pacira Pharmaceuticals

Pacira Pharmaceuticals announced the completion of two Phase III placebo-controlled studies evaluating the efficacy, safety and pharmacokinetics of Exparel (bupivacaine liposome injectable suspension) as a single-dose nerve block for prolonged regional analgesia. The first study evaluated Exparel administered as a brachial plexus block for patients undergoing one of two upper extremity surgeries (total shoulder arthroplasty or rotator cuff repair), and the second study evaluated Exparel administered as a femoral nerve block for patients undergoing a lower extremity surgical procedure (total knee arthroplasty, or TKA). In the upper extremity study, Exparel demonstrated statistical significance for the primary endpoint of cumulative pain scores over 48 hours as measured by the area under the curve. Exparel also achieved statistical significance versus placebo for the study’s key secondary endpoints as follows: total postsurgical opioid consumption through 48 hours; opioid-free subjects through 48 hours; and time to first opioid rescue through 48 hours. The preliminary safety analysis was consistent with previously reported studies of brachial plexus nerve blocks with bupivacaine. In the lower extremity study, Exparel did not demonstrate statistical significance in the femoral nerve block study due to a significant deviation from protocol identified at a single center. When these patients were excluded from the analyses, patients receiving 266 mg Exparel achieved statistical significance versus placebo for the study’s primary endpoint of cumulative pain scores over 72 hours as measured by the area under the curve.